We are a world leader in dendrimer technology for medical applications. As an innovative Australian biopharmaceutical company, we are focussed on developing and commercialising novel therapeutic products that address significant global healthcare needs. We boast a strong portfolio of products, partnerships, and intellectual property. Our innovative technology is based on proprietary polymers called dendrimers, which are precise, synthetically manufactured, nanoscale molecules. The unique properties of dendrimers – including their size, structure, high degree of branching, polyvalency, and water solubility – are advantageous in medical and pharmaceutical applications. Our drug delivery platform is being used to enhance the effectiveness of existing and novel therapies and to reduce drug-related toxicities through controlled and specified drug delivery. We are now registered in more than 35 countries*, including Europe, the UK, and Asia. This role contributes to research and experimental studies for the discovery and development of drugs for diseases. As part of the Clinical Development team, the role organises and oversees tests of new drugs and medicines, collates, produces, analyses and effectively communicates clinical trials data, and provides a wide range of support in relation to studies and clinical team operations. To apply for this position you must have a Degree in Pharmacy, Pharmacology or related discipline; PhD/Masters would be preferred. You will need over 4 years’ experience in the Biotechnology or Pharmaceutical industry and Prior experience in clinical trial monitoring and data management, preferably in oncology studies. We are offering $70K - $80K
Key accountabilities;
• Ensuring accuracy and quality of data across multiple clinical studies by reviewing clinical trial databases (consistency vs
source, protocol), raising queries and following their resolutions, implementing and updating trackers, drawing key
summaries of data, updating internal patients’ files, reconciling data with safety listings from pharmacovigilance database;
• Assisting with the production and effective communication of a range of study status reports including announcements,
abstracts, poster, headline safety and efficacy data summaries;
• Providing input into clinical trial protocol design and execution to ensure clinical drug development objectives are met;
• Providing ongoing support for data management and statistical activities with internal team, CRO and subcontractors,
including review of Statistical Analysis Plans, programming specifications, shells and final drafts of statistical tables, listings
and figures;
• Providing ongoing support for clinical trial monitoring activities with sites and CROs, including reviewing, managing and
filing of clinical trial documentation, reviewing monitoring visit reports to ensure that they reflect an accurate picture of
SDV activities recorded in the case report form;
• Use of Tableau 2023.1 and Tableau Prep Builder 2023.2 for data analyses and presentations;
• Assisting with study materials and supplies including ensuring quality control throughout clinical trial conduct and securing
approval for their use and distribution, ordering, tracking, receipt and release (applicable to trial drug supplies and biological
sample management);
• Reviewing and updating patient visit and procedures trackers to facilitate accurate financial accruals and providing updates
to the finance team;
• Supporting Clinical Development team with contractual negotiations and financial management (eg, understanding key
clinical agreements, tracking expenditure against budgets/forecast/Board approved amounts, invoice management,
working with Finance team on budgeting and forecasting processes and financial reporting requirements, and assist with
timely review and execution of new agreements/work orders/protocol amendments);
• Providing support for regulatory needs and discussions;
• Coordinating internal meetings with relevant members of the study team and preparing meeting minutes as required;
• Maintaining awareness of and compliance with all Company policies and procedures (Corporate, Quality, Safety and
Finance) and ensure company valued behaviours are adhered to;
• Assisting with the identification, analysis and management of risks associated with areas of responsibility and expertise;
• Other activities as requested by Management.
Please provide Resume and Qualifications if you are interested. Only shortlisted applicants will be contacted.
Key accountabilities;
• Ensuring accuracy and quality of data across multiple clinical studies by reviewing clinical trial databases (consistency vs
source, protocol), raising queries and following their resolutions, implementing and updating trackers, drawing key
summaries of data, updating internal patients’ files, reconciling data with safety listings from pharmacovigilance database;
• Assisting with the production and effective communication of a range of study status reports including announcements,
abstracts, poster, headline safety and efficacy data summaries;
• Providing input into clinical trial protocol design and execution to ensure clinical drug development objectives are met;
• Providing ongoing support for data management and statistical activities with internal team, CRO and subcontractors,
including review of Statistical Analysis Plans, programming specifications, shells and final drafts of statistical tables, listings
and figures;
• Providing ongoing support for clinical trial monitoring activities with sites and CROs, including reviewing, managing and
filing of clinical trial documentation, reviewing monitoring visit reports to ensure that they reflect an accurate picture of
SDV activities recorded in the case report form;
• Use of Tableau 2023.1 and Tableau Prep Builder 2023.2 for data analyses and presentations;
• Assisting with study materials and supplies including ensuring quality control throughout clinical trial conduct and securing
approval for their use and distribution, ordering, tracking, receipt and release (applicable to trial drug supplies and biological
sample management);
• Reviewing and updating patient visit and procedures trackers to facilitate accurate financial accruals and providing updates
to the finance team;
• Supporting Clinical Development team with contractual negotiations and financial management (eg, understanding key
clinical agreements, tracking expenditure against budgets/forecast/Board approved amounts, invoice management,
working with Finance team on budgeting and forecasting processes and financial reporting requirements, and assist with
timely review and execution of new agreements/work orders/protocol amendments);
• Providing support for regulatory needs and discussions;
• Coordinating internal meetings with relevant members of the study team and preparing meeting minutes as required;
• Maintaining awareness of and compliance with all Company policies and procedures (Corporate, Quality, Safety and
Finance) and ensure company valued behaviours are adhered to;
• Assisting with the identification, analysis and management of risks associated with areas of responsibility and expertise;
• Other activities as requested by Management.
Please provide Resume and Qualifications if you are interested. Only shortlisted applicants will be contacted.
